Comparative safety and efficacy of tibolone and escitalopram in postmenopausal women

Abstract

Background: A high prevalence of psychiatric disorders, particularly depressive and anxiety disorders among women is observed through the postmenopausal stage. Aim: The aim of this study is to compare the safety and efficacy of tibolone (TIB) and escitalopram (ESCIT) in postmenopausal women (PMW). Materials and Methods: It was an interventional, open-label, hospital-based, follow-up study conducted on 60 PMW with the diagnosis of depression as per the Diagnostic and Statistical Manual of Mental Disorder-5 criteria. Patients were divided into two groups of 30 each, i.e. Group I (TIB-2.5 mg/day) and Group II (ESCIT-10–20 mg/day). The primary outcome was assessed for change in climacteric symptom scores on Greene's Climacteric Scale (GCS), severity of depression and anxiety on Hamilton Rating Scale for Depression (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A), and sexual functioning on Arizona Sexual Experience Scale (ASEX). The secondary outcome of well-being was assessed on World Health Organization Quality of life (QOL)-BREF. All the observations were carried out from baseline and at 2, 4, 8, and 12 weeks. Results: Both the groups showed significant improvement in climacteric and depressive symptoms. However, at the 8th and 12th weeks, mean ± standard deviation scores were significantly lower in Group I (GCS score - 24.80 ± 4.92, 20.30 ± 3.56; HAM-D score - 16.57 ± 5.83, 10.2 ± 5.67) compared to Group II (GCS score - 27.27 ± 5.83 and 23.33 ± 5.70, HAM-D score - 19.97 ± 7.98 and 16.17 ± 10.11). No significant difference between the groups was seen for anxiety on HAM-A scores. Only in Group I, there was significant improvement in ASEX scores. QoL in Group I had shown significant improvement in physical and psychological domain compared to Group II at different time interval, i.e. 4th and 8th week onward. In Group I, Alternative Dispute Resolution was reported to be 23.3%, whereas it was 56.7% in Group II. However, none were serious to warrant discontinuation. Conclusion: TIB was better than ESCIT in improving depression, climacteric symptoms, and physical and psychological domain of QoL with an additional benefit of restoring sexual functioning.